Carcinoma, Non-Small-Cell LungPhase 2COPERNICUSNCT06667076

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Amivantamab, Lazertinib and Chemotherapy: Pemetrexed in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 205 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
What is being tested?: Amivantamab, Lazertinib and Chemotherapy: Pemetrexed
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 480 participants
Where: 205 sitesin 14 countries
Study dates: 16 Dec 2024to 26 Dec 2030
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended
Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia [any grade], grade <=2 peripheral neuropathy, or grade <=2 hypothyroidism stable on hormone replacement)
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Who cannot join

Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis
Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)
Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study
Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)

Trial locations and contacts

205 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Country

City, postcode or hospital

Sites recruiting now only

205 sites in 14 countries

United States150 sites, 13 recruiting

University of New Mexico
Albuquerque, New Mexico, 87102
Completed
Accellacare of McFarland
Ames, Iowa, 50010
Active, not recruiting
University of Michigan Health System
Ann Arbor, Michigan, 48105
Completed
University Cancer And Blood Center LLC
Athens, Georgia, 30607
Completed
Grady Health System Correll Pavilion
Atlanta, Georgia, 30303
Recruiting
Piedmont Healthcare
Atlanta, Georgia, 30309
Completed
Piedmont Cancer Institute
Atlanta, Georgia, 30318
Active, not recruiting
Winship Cancer Institute Emory University
Atlanta, Georgia, 30322
Active, not recruiting
Texas Oncology South
Austin, Texas, 78745
Active, not recruiting
University of Maryland
Baltimore, Maryland, 21201
Recruiting
Baptist Lynn Cancer Institute
Boca Raton, Florida, 33486
Active, not recruiting
Boston University Medical Center
Boston, Massachusetts, 02118
Active, not recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Active, not recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Active, not recruiting
Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Completed
The Oncology Institute of Hope and Innovation
Cerritos, California, 90703
Active, not recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Active, not recruiting
Atrium Health
Charlotte, North Carolina, 28204
Active, not recruiting
Tennessee Oncology - Chattanooga
Chattanooga, Tennessee, 37404
Active, not recruiting
Rush University Medical Center Rush University Cancer Center Chicago
Chicago, Illinois, 60607
Active, not recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Active, not recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
Completed
Cincinnati Veterans Affairs Medical Center
Cincinnati, Ohio, 45220
Completed
City of Hope Corona
Corona, California, 92882
Active, not recruiting
Parkland Health and Hospital System
Dallas, Texas, 75235
Recruiting
Texas Oncology DFW
Dallas, Texas, 75246
Active, not recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Active, not recruiting
Southern Cancer Center, PC
Daphne, Alabama, 36526
Active, not recruiting
Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526
Completed
National Jewish Health
Denver, Colorado, 80206
Completed
Saint Josephs Hospital Cancer Centers of Colorado
Denver, Colorado, 80218
Completed
City of Hope
Duarte, California, 91010
Active, not recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Completed
Hematology-Oncology Associates of CNY
East Syracuse, New York, 13057
Active, not recruiting
Renovatio Clinical
El Paso, Texas, 79915
Completed
Oncology Associates of Oregon PC Willamette Valley Cancer Institute
Eugene, Oregon, 97401
Active, not recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Active, not recruiting
University of Kansas Cancer Center
Fairway, Kansas, 66205
Active, not recruiting
Hunterdon Hematology Oncology
Flemington, New Jersey, 08822
Completed
The Oncology Institute of Hope and Innovation 1
Fort Lauderdale, Florida, 33316
Active, not recruiting
Florida Cancer Specialists
Fort Myers, Florida, 33916
Active, not recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
Active, not recruiting
JPS Health Network
Fort Worth, Texas, 76104
Completed
Univ of Florida
Gainesville, Florida, 32610
Active, not recruiting
Oncology Physicians Network Healthcare
Glendale, California, 91203
Completed
Los Angeles Cancer Network
Glendale, California, 91204
Active, not recruiting
Glendale Adventist Medical Center
Glendale, California, 91206
Completed
Lutheran Hospital Cancer Centers of Colorado
Golden, Colorado, 80401
Completed
City of Hope Phoenix
Goodyear, Arizona, 85338
Active, not recruiting
Marin Cancer Center
Greenbrae, California, 94904
Completed
Hope and Healing Cancer Services
Hinsdale, Illinois, 60521
Completed
Memorial Regional Hospital
Hollywood, Florida, 33021 5421
Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Active, not recruiting
Oncology Consultants Texas
Houston, Texas, 77030
Active, not recruiting
City of Hope Seacliff
Huntington Beach, California, 92648
Active, not recruiting
Clearview Cancer Institute
Huntsville, Alabama, 35805
Completed
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
Active, not recruiting
Jackson Oncology Associates
Jackson, Mississippi, 39202
Completed
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Active, not recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Active, not recruiting
Truman Medical Ctr West
Kansas City, Missouri, 64108
Recruiting
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909
Active, not recruiting
University of Tennessee
Knoxville, Tennessee, 37920
Active, not recruiting
University of California San Diego Health
La Jolla, California, 92093
Active, not recruiting
City of Hope Antelope Valley
Lancaster, California, 93534
Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Active, not recruiting
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124
Active, not recruiting
City of Hope Long Beach Elm
Long Beach, California, 90813
Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
Active, not recruiting
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Active, not recruiting
Cedars Sinai Medical Center
Los Angeles, California, 90048
Active, not recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
Active, not recruiting
Baptist Cancer Center
Memphis, Tennessee, 38120
Completed
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Completed
Baptist Health Miami Cancer Institute
Miami, Florida, 33176
Active, not recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, 11501
Active, not recruiting
University Of Minnesota
Minneapolis, Minnesota, 55455
Completed
Providence Medical Foundation
Mission Viejo, California, 92691
Active, not recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
Active, not recruiting
Valkyrie Clinical Trials Murrieta
Murrieta, California, 92562
Active, not recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
Active, not recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Active, not recruiting
Yale New Haven Hospital Yale Cancer Center
New Haven, Connecticut, 06520
Active, not recruiting
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
New York, New York, 10016
Active, not recruiting
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, 10032
Completed
ChristianaCare Helen F Graham Cancer Center and Research Institute
Newark, Delaware, 19713
Active, not recruiting
City of Hope Cancer Center
Newnan, Georgia, 30265
Active, not recruiting
Illinois Cancer Specialists
Niles, Illinois, 60714
Completed
Investigative Clinical Research of Indiana, LLC
Noblesville, Indiana, 46062
Active, not recruiting
Kaiser Permanente Oakland Medical Center
Oakland, California, 94611
Completed
Texas Oncology Odessa-West Texas Cancer Center
Odessa, Texas, 79761
Completed
Vista Oncology
Olympia, Washington, 98506
Active, not recruiting
St. Joseph Hospital Center for Cancer Prevention and Treatment
Orange, California, 92868
Completed
University of California Irvine
Orange, California, 92868
Active, not recruiting
AdventHealth Orlando
Orlando, Florida, 32803
Active, not recruiting
Orlando Health Cancer Institute
Orlando, Florida, 32806
Active, not recruiting
Sutter Health Palo Alto Medical Foundation
Palo Alto, California, 94301
Completed
Lankenau Institute for Medical Research Main Line Health Paoli Hospital
Paoli, Pennsylvania, 19301
Completed
Memorial Cancer Institute
Pembroke Pines, Florida, 33026
Recruiting
Illinois CancerCare
Peoria, Illinois, 61615
Active, not recruiting
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, 19104
Completed
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Active, not recruiting
Jefferson Health Northeast
Philadelphia, Pennsylvania, 19114
Completed
Oregon Health And Science University
Portland, Oregon, 97239
Active, not recruiting
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Active, not recruiting
Kaiser Permanente Roseville Medical Center
Roseville, California, 95661
Completed
UC Davis Comprehensive Cancer Center
Sacramento, California, 95630
Active, not recruiting
Sutter Institute for Medical Research
Sacramento, California, 95816
Completed
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Active, not recruiting
Texas Oncology San Antonio Northeast
San Antonio, Texas, 78217
Active, not recruiting
California Pacific Medical Center
San Francisco, California, 94115
Completed
Kaiser Permanente San Francisco Medical Center
San Francisco, California, 94115
Completed
UCSF Zuckerberg San Francisco General Hospital
San Francisco, California, 94143
Active, not recruiting
Sansum Clinic
Santa Barbara, California, 93105
Active, not recruiting
Kaiser Permanente Santa Clara Medical Center
Santa Clara, California, 95051
Active, not recruiting
Providence Medical Foundation 1
Santa Rosa, California, 95403
Active, not recruiting
Ellis Hospital
Schenectady, New York, 12308
Active, not recruiting
New York Cancer and Blood Specialists
Shirley, New York, 11967
Active, not recruiting
Maryland Oncology Hematology P A
Silver Spring, Maryland, 20904
Active, not recruiting
Avera Medical Group
Sioux Falls, South Dakota, 57105
Completed
City of Hope South Pasadena
South Pasadena, California, 91030
Recruiting
Summit Cancer Centers
Spokane, Washington, 99208
Active, not recruiting
Community Clinical Trials
Spring, Texas, 77389
Completed
Oncology Hematology Associates
Springfield, Missouri, 65807
Completed
Washington University School Of Medicine
St Louis, Missouri, 63110
Active, not recruiting
Florida Cancer Specialists & Research Institute 1
St. Petersburg, Florida, 33701
Active, not recruiting
Overlook Medical Center
Summit, New Jersey, 07901
Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Active, not recruiting
Holy Name Medical Center
Teaneck, New Jersey, 07666
Completed
Montefiore Medical Center
The Bronx, New York, 10461
Active, not recruiting
Renovatio Clinical 1
The Woodlands, Texas, 77380
Completed
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75701
Active, not recruiting
Texas Oncology - Northeast
Tyler, Texas, 75702
Active, not recruiting
City of Hope Upland
Upland, California, 91786
Recruiting
Kaiser Permanente Northern California
Vallejo, California, 94589
Active, not recruiting
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, 98684
Completed
Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California, 94596
Active, not recruiting
John Muir Health Clinical Research Center
Walnut Creek, California, 94598
Active, not recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Active, not recruiting
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422
Completed
Texas Oncology-Gulf Coast
Webster, Texas, 77598
Completed
Florida Cancer Specialists & Research Institute
West Palm Beach, Florida, 33401
Active, not recruiting
McGlinn Cancer Institute Reading Hospital
West Reading, Pennsylvania, 19611
Active, not recruiting
Clinical Research Alliance Inc
Westbury, New York, 11590
Completed
Regional Medical Oncology Center
Wilson, North Carolina, 27893
Active, not recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Completed
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
Completed
Trinity Health St Joseph Mercy Ann Arbor
Ypsilanti, Michigan, 48197
Active, not recruiting
City of Hope Chicago
Zion, Illinois, 60099
Recruiting

Other trials in United States

Portugal6 sites, 6 recruiting

Uls Braga - Hosp. Braga
Braga, 4710 243
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Uls Alto Ave - Hosp. Sra. Da Oliveira Guimaraes
Guimarães, 4835 044
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Hosp. Cuf Tejo
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Uls Loures Odivelas - Hosp. Loures
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Ipo Porto
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Uls Gaia Espinho
Vila Nova de Gaia, 4434 502
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United Kingdom6 sites, 6 recruiting

Guy's and St Thomas' NHS Foundation Trust
Greater London, SE1 9RT
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The Clatterbridge Cancer Centre NHS Foundation Trust
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Royal Marsden Hospital 1
London, SW3 6JJ
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The Christie NHS Foundation Trust Christie Hospital
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Royal Marsden Hospital
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Greece5 sites, 5 recruiting

Henry Dunant Hospital Center
Athens, 115 26
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Thoracic General Hospital Of Athens I Sotiria
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Metaxa Cancer Center Hospital Of Piraeus
Piraeus, 18537
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Anticancer Hospital of Thessaloniki Theageneio
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Athens Medical Center S A Interbalkan Medical Center of Thessaloniki
Thessaloniki, 54639
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Italy5 sites, 5 recruiting

Aou San Luigi Gonzaga
Orbassano, 10043
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Istituto Oncologico Veneto - IRCCS
Padova, 35128
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Ospedale S. Maria Delle Croci
Ravenna, 48121
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Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168
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Istituto Clinico Humanitas
Rozzano, 20089
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Poland5 sites, 5 recruiting

Centrum Onkologii im Prof F Lukaszczyka
Bydgoszcz, 85 796
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Centrum Pulmonologii i Torakochirurgii w Bystrej
Bystra, 43 360
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Uniwersyteckie Centrum Kliniczne
Gdansk, 80 952
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Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
Olsztyn, 10-357
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Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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Spain5 sites, 5 recruiting

Hosp Univ Vall D Hebron
Barcelona, 08035
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Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407
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Hosp. Univ. 12 de Octubre
Madrid, 28041
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Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706
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Hosp. Univ. I Politecni La Fe
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Genk, 3600
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Ghent University Hospital
Ghent, 9000
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Universitair Ziekenhuis Leuven
Leuven, 3000
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CHU UCL Namur - Site Godinne
Yvoir, 5530
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CHU de Grenoble
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About this study

Official title: A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Conditions: Carcinoma, Non-Small-Cell Lung
Being tested: Amivantamab, Lazertinib, Chemotherapy: Pemetrexed, Chemotherapy: Carboplatin
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AmivantamabDrug
Also called JNJ-61186372
Amivantamab will be administered.
LazertinibDrug
Also called JNJ-73841937
Lazertinib tablet will be administered.
Chemotherapy: PemetrexedDrug
Pemetrexed will be administered.
Chemotherapy: CarboplatinDrug
Carboplatin will be administered.

Study groups in NCT06667076
Study group	Role	What they receive
Cohort 1: Amivantamab and Lazertinib	Experimental	Participants will receive Amivantamab in combination with Lazertinib orally in 28-day cycles until disease progression, withdrawal of consent, death, or the investigator decides to discontinue treatment, whichever comes first. Receives: Drug: Amivantamab; Drug: Lazertinib
Cohort 2: Amivantamab and Chemotherapy	Experimental	Participants will receive Amivantamab in combination with chemotherapy (carboplatin and pemetrexed) intravenous (IV) infusion in 21-day cycles until disease progression, withdrawal of consent, death, or the investigator decides to discontinue treatment, whichever comes first. Receives: Drug: Amivantamab; Drug: Chemotherapy: Pemetrexed; Drug: Chemotherapy: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS)
PFS is defined as the time from the date of first dose of any study treatment until the date of objective disease progression or death, whichever occurs first according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 as assessed by the investigator.
Measured: Up to 4 Years and 6 months

Secondary outcomes (11)

Number of Participants Reporting Dose Reductions, Interruptions, and Discontinuations
Participants with dose reductions, interruptions, and discontinuations will be reported.
Measured: Up to 4 Years and 6 months
Number of Participants With Venous Thromboembolic Events (VTEs)
Participants with signs and symptoms (dyspnea, tachypnea, upper- or lower-extremity swelling and discoloration) of VTE events, specifically pulmonary embolism, and deep vein thrombosis will be reported as monitored by the investigators.
Measured: Up to 4 Years and 6 months
Number of Participants With Dermatologic Adverse Events (AEs)
Participants with dermatologic AEs will be reported.
Measured: Up to 4 Years and 6 months
Number of Participants with AEs by Severity
Severity of AEs will be graded according to the national cancer institute common terminology criteria for adverse event (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening and Grade 5: death related to adverse event.
Measured: Up to 4 Years and 6 months
Overall Survival (OS)
OS is defined as the time from the date of first dose of any study treatment until the date of death due to any cause.
Measured: Up to 4 Years and 6 months
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve either a partial response (PR) or complete response (CR) as their best response both confirmed and unconfirmed, as defined using RECIST v1.1.
Measured: Up to 4 Years and 6 months
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants achieving CR or PR, both confirmed and unconfirmed, or durable stable disease (SD) of a duration of at least 11 weeks as defined using RECIST v1.1.
Measured: Up to 4 Years and 6 months
Duration of Response (DOR)
DOR is defined as the time from the date of first documented response (PR or CR) until the date of documented progression or death, whichever occurs first, for participants who have PR or CR.
Measured: Up to 4 Years and 6 months
Time to Treatment Discontinuation (TTTD)
TTTD is defined as the date from the date of first dose of any study treatment until discontinuation of study treatment for any reason, including disease progression, treatment toxicity or death, based on RECIST v 1.1.
Measured: Up to 4 Years and 6 months
Time to Subsequent Therapy (TTST)
TTST is defined as the time from the date of first dose of any study treatment until the start date of the subsequent anticancer therapy following study treatment discontinuation or death, whichever occurs first.
Measured: Up to 4 Years and 6 months
Time to Symptomatic Progression (TTSP)
TTSP is defined as the time from date of first dose of any study treatment to documentation in the electronic case report form (eCRF) of any of the following (whichever occurs earlier): onset of new symptoms or symptom worsening that is considered by the investigator to be related to lung cancer and requires either a change in systemic anticancer treatment and/or clinical intervention to manage symptoms or death.
Measured: Up to 4 Years and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 202426 Dec 2030

First posted31 Oct 2024
Study start16 Dec 2024
Primary completion23 May 2029 (estimated)
Study completion26 Dec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 480 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06667076
Sponsor's protocol ID: 61186372NSC2012
Other IDs: 61186372NSC2012, 2025-520730-28-00, 2025
Acronym: COPERNICUS
Status last verified: Nov 2026
First submitted: 30 Oct 2024
Last updated: 3 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06667076
Acronym / sponsor ID: COPERNICUS / 61186372NSC2012
Conditions: Carcinoma, Non-Small-Cell Lung
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 480 participants (estimated)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 16 Dec 2024 (actual)
Primary completion: 23 May 2029 (estimated)
Study completion: 26 Dec 2030 (estimated)
First posted: 31 Oct 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1: Amivantamab and Lazertinib	Experimental	Drug: Amivantamab, Drug: LazertinibParticipants will receive Amivantamab in combination with Lazertinib orally in 28-day cycles until disease progression, withdrawal of consent, death, or the investigator decides to discontinue treatment, whichever comes first.
Cohort 2: Amivantamab and Chemotherapy	Experimental	Drug: Amivantamab, Drug: Chemotherapy: Pemetrexed, Drug: Chemotherapy: CarboplatinParticipants will receive Amivantamab in combination with chemotherapy (carboplatin and pemetrexed) intravenous (IV) infusion in 21-day cycles until disease progression, withdrawal of consent, death, or the investigator decides to discontinue treatment, whichever comes first.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended
Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia [any grade], grade <=2 peripheral neuropathy, or grade <=2 hypothyroidism stable on hormone replacement)
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

Key exclusion criteria (5 listed)

Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis
Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)
Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study
Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AmivantamabAlso: JNJ-61186372Amivantamab will be administered.	Drug	Cohort 1: Amivantamab and Lazertinib, Cohort 2: Amivantamab and Chemotherapy
LazertinibAlso: JNJ-73841937Lazertinib tablet will be administered.	Drug	Cohort 1: Amivantamab and Lazertinib
Chemotherapy: PemetrexedPemetrexed will be administered.	Drug	Cohort 2: Amivantamab and Chemotherapy
Chemotherapy: CarboplatinCarboplatin will be administered.	Drug	Cohort 2: Amivantamab and Chemotherapy

Primary outcome

Progression Free Survival (PFS)
Time frame: Up to 4 Years and 6 months
PFS is defined as the time from the date of first dose of any study treatment until the date of objective disease progression or death, whichever occurs first according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 as assessed by the investigator.

11 secondary outcomes

Number of Participants Reporting Dose Reductions, Interruptions, and Discontinuations
Time frame: Up to 4 Years and 6 months
Number of Participants With Venous Thromboembolic Events (VTEs)
Time frame: Up to 4 Years and 6 months
Number of Participants With Dermatologic Adverse Events (AEs)
Time frame: Up to 4 Years and 6 months
Number of Participants with AEs by Severity
Time frame: Up to 4 Years and 6 months
Overall Survival (OS)
Time frame: Up to 4 Years and 6 months
Overall Response Rate (ORR)
Time frame: Up to 4 Years and 6 months
Clinical Benefit Rate (CBR)
Time frame: Up to 4 Years and 6 months
Duration of Response (DOR)
Time frame: Up to 4 Years and 6 months
Time to Treatment Discontinuation (TTTD)
Time frame: Up to 4 Years and 6 months
Time to Subsequent Therapy (TTST)
Time frame: Up to 4 Years and 6 months
Time to Symptomatic Progression (TTSP)
Time frame: Up to 4 Years and 6 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

205 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amivantamab, Lazertinib and Chemotherapy: Pemetrexed in people with Carcinoma, Non-Small-Cell Lung, run by Janssen Research & Development, LLC at 205 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 205 sites in United States, Portugal, United Kingdom, Greece, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Up to 4 Years and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06667076.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.